FDA.report

Calibration Pump

Primary DI
04250892900995
Brand
Calibration Pump
Company
Vyaire Medical GmbH
Model
706596
Catalog number
706596
Device description
Calibration Pump 3 Liter
Published
2017-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BXWCalibrator, Volume, Gas

Product Code Classifications

CodeDeviceSpecialtyClass
BXWCalibrator, Volume, GasAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250892900995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250892900995042508929009954250892900995

GMDN Terms

TermDefinition
Gas volume reference standardA manual instrument intended to deliver a precise, known quantity of gas (e.g., 1 litre) for the purposes of calibrating/testing a medical device partially or completely dedicated to measuring/monitoring volumes of air/gas (e.g., anaesthesia monitor, diagnostic spirometer). It is typically presented as a syringe-like device with a manually-operated plunger and may include appropriate connecting tubing. This device is intended to be used by a healthcare provider in a clinical setting.

Sterilization Methods

Method

Contacts

PhoneEmail
+499314972127support.rt.eu@carefusion.com

Regulatory Flags

DUNS number
329769991
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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14250892906697Vyaire36-MFA101036-MFA10102021-09-24
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008171360268005570 3L SYRINGEHANS RUDOLPH, INC.BXW2022-03-08
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